In this post hoc analysis of LEADER, the effects of liraglutide were assessed in patients with or without atherosclerotic poly-vascular disease in more than 1 vascular bed (coronary, cerebrovascular, and peripheral).

LEADER was a randomized trial of liraglutide (1.8 mg or maximum tolerated dose) versus placebo in 9,340 patients with T2DM and high CV risk (median follow-up: 3.8 years). The primary outcome was MACE, a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke. The key secondary outcome (expanded MACE) also included hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure.

The risk reduction in MACE and expanded MACE in patients with single and poly-vascular disease was similar to that of the total trial population in LEADER.

In patients without atherosclerotic CVD at baseline, the HR for liraglutide versus placebo for MACE was 1.08 (95%CI: 0.84–1.38), with similar results for expanded MACE and CV death.

No significant interaction was found among risk groups, except for expanded MACE (P=0.03), This latter finding might be driven by the group of patients without atherosclerotic CVD.

Conclusion

In patients with T2DM and documented atherosclerotic CVD, the presence of poly-vascular disease was associated with a higher CV risk compared with single vascular disease patients. Liraglutide consistently reduced major CV outcomes in both groups.